GuidelinesBy procedure2026.09.30
A Startup’s First Korean Device Submission: Decisions to Make Before Paying for Tests
A first submission depends on when the product and manufacturing model are defined. Map the decisions, evidence owners and entry conditions needed at each stage of development and regulatory preparation.
1. Turn the investor description into a reviewable definition
A “smart solution for health management” does not define a product category or evidence scope. Separate what it measures, what information it provides, which decisions users make from that information, and the intended population and setting. If diagnosis or treatment claims are proposed, consider how their performance will be supported. A one-page product definition is a workable starting point.
Identify the models, software functions and accessories included in this submission; separate future functions. Including undeveloped functions in instructions may expand the evidence needed. Start classification with the medical-device status guide.
2. Decide the product route and the company’s role together
Do not order tests on the strength of a class number alone. Review the product definition, approval/certification/notification route, technical and clinical evidence needs, and any separate legislative framework. Digital products and IVDs need their own applicability assessment.
At the same time, identify the manufacturer or importer, the design owner and each production location. An OEM contract does not automatically allocate all manufacturing and quality responsibilities. Agree activities at each site, data ownership, change notification and audit cooperation so that evidence will actually be available. Use the manufacturer licensing guide for business-side preparation.
3. Compare required evidence with evidence already held
The following is an internal planning template, not a universal testing list. Record why each row applies or does not apply, reducing unnecessary quotations and late omissions.
| Review area | Information to obtain now | Decision before starting |
|---|---|---|
| Performance | Range, accuracy and use conditions | Link each claim to acceptance criteria |
| Safety | Construction, materials, contact and power information | Standards and representative samples |
| Software | Functions, versions and external components | Requirement-to-test traceability |
| Manufacturing/quality | Process map and site roles | KGMP scope and record ownership |
| Labeling | Intended use and draft instructions | Alignment of limitations and actual functions |
For overseas reports, check more than file availability. Compare the model, site, sample specification, standard edition and change history, then assess Korean usability. Decide whether a gap needs additional testing or explanatory evidence against the relevant requirement.
4. Build the schedule around entry conditions
Booking laboratory time does not prevent rework if materials or circuitry change. Break “ready for testing” into configuration approval, risk review, agreement on standards and sample quantities and history. Separate base testing from sample production, translation, follow-up work and possible retesting in the budget.
Parallel work is useful when dependencies permit it. Process documentation and quality-system preparation can advance while tests run, but an unverified performance value should not become a final label claim. Assign real decision-makers and document authors rather than company names. Give every open question a condition for the next decision.
5. Reconcile shared values before submission
The final review is not a count of documents. Confirm that product and model names, intended use, manufacturing sites, versions and performance ranges identify the same device across the application, reports, risk file and instructions. Determine whether a difference is a clerical error or a design change, and record its impact.
Retain failed development results with the corrective work and re-verification. Identify who will answer review questions and where raw data are stored. Check route-specific requirements and fees when filing, and distinguish internal target dates from administrative processing periods.
6. Include first-shipment conditions
Do not assume that finishing the product procedure alone authorizes immediate shipment. Check the business license, applicable quality requirements, final labeling, traceability information, release approval and post-market procedures. Record completion evidence for each condition that applies.
The first useful tools are a product definition, evidence-gap table and owner-based schedule. When they agree, requests to laboratories and manufacturers become clear. Send the product description and evidence inventory for a first-submission review; we can identify the decisions to settle first and preparation that can proceed alongside them.
Sources checked: 2026-09-28. The tables and preparation steps are practical suggestions; confirm the legal submission scope and applicable standards for the particular product.
Frequently asked questions
- Q. Can preparation start before the prototype is finished?
- Yes. Intended use, configuration, users and the manufacturing model can be defined early. Plan formal testing when you can explain how the samples represent the finished device.
- Q. Does Class II mean one standard route?
- No. Product characteristics, equivalence, clinical evidence needs and possible digital or IVD legislation also affect the route.
- Q. Can we fix the total duration first?
- Not reliably before reviewing sample readiness, existing evidence, the review route and potential questions. First establish entry conditions and tasks that can run in parallel.